BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE TOTAL A-CLASS HEAD

    MDR report key: 1295328 · Received January 15, 2009

    Report

    Report Number
    1043534-2009-00012
    Event Type
    Injury
    Date Received
    January 15, 2009
    Date of Event
    October 21, 2008
    Report Date
    January 14, 2009
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    KWY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE ADDITIONAL PRODUCT WAS REVISED: CONSERVE TOTAL A-CLASS HEAD. INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-08-00318, 00319.

    Description of Event or Problem · 1

    ALLEGEDLY REVISED DUE TO BROKEN NECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSERVE TOTAL A-CLASS HEAD HIP COMPONENT KWY WRIGHT MEDICAL TECHNOLOGY, INC. NA 026285592

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Hospitalization| R